Kornimate/medical-research-clean huggingface dataset:
thalidomide, doxorubicin, and dexamethasone in treating patients with untreated stage ii or stage iii multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: thalidomide may stop the growth of multiple myeloma by stopping blood flow to the cancer cells. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining thalidomide with chemotherapy may kill more cancer cells. purpose: phase ii trial to study the effectiveness of thalidomide, doxorubicin, and dexamethasone in treating patients who have untreated stage ii or stage iii multiple myeloma.

objectives: i. determine the response rate of patients with previously untreated stage ii or iii multiple myeloma treated with thalidomide, doxorubicin, and dexamethasone. ii. determine the safety and toxicity of this regimen in this patient population. outline: patients receive oral dexamethasone on days 1-4, 9-12, and 17-20, doxorubicin iv on day 1, and oral thalidomide daily. treatment repeats every 30 days for 4 courses in the absence of unacceptable toxicity or disease progression. projected accrual: a total of 21-45 patients will be accrued for this study within approximately 1 year.

Eligibility criteria:
disease characteristics: histologically confirmed multiple myeloma stage ii disease symptomatic due to progressive disease or stage iii disease no stage i multiple myeloma or smoldering myeloma patient characteristics: age: 18 and over performance status: ecog 0-3 life expectancy: more than 4 months hematopoietic: absolute granulocyte count at least 1,500/mm3\* platelet count at least 100,000/mm3\* \*unless due to multiple myeloma hepatic: bilirubin no greater than 2.0 mg/dl alt and ast no greater than 3 times upper limit of normal (uln) alkaline phosphatase no greater than 3 times uln renal: elevated creatinine allowed cardiovascular: lvef at least 50% by muga or echo no active angina no myocardial infarction within the past 6 months other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception at least 4 weeks prior to, during, and for at least 4 weeks after study no grade ii or greater pre-existing neuropathy no other concurrent or prior active malignancy within the past 2 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix prior t1a or t1b prostate cancer (detected incidentally at transurethral resection of prostate (turp) and comprising less than 5% of resected tissue) allowed if psa normal since turp hiv negative no aids-related illness no other medical condition that would preclude study prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy for multiple myeloma endocrine therapy: no more than 1 course of prior pulse dexamethasone prior steroids of less than 1 month duration for emergent indications or life-threatening lesions (e.g., hypercalcemia or spinal cord compromise) allowed radiotherapy: prior radiotherapy allowed surgery: not specified

Keywords: stage ii multiple myeloma stage iii multiple myeloma
activation of brown adipose tissue metabolism using mirabegron

Conditions: Type 2 Diabetes

Summary: could sympathomimetics and sympatholytics drugs safe for the management of type 2 diabetes (t2d)? based on recent evidence, we propose that pharmacological stimulation of beta-3 adrenergic receptor (adbr3) at higher doses of mirabegron may be required to elicit changes in glycemia, but should be combined with beta-1 adrenergic receptor (adrb1) antagonists to suppress the unwanted effects on the cardiovascular system. together, several results establish a previously unappreciated cross-talk between gs-coupled adrb1 and adrb3 in adipose tissue for the control of glucose homeostasis. moreover, these data suggest that antagonizing adrb1 may be a good way to significantly lower the dose of adrb3 agonist required for glucose control. therefore, we believe that there are therapeutic opportunities in targeting adrenergic receptors for the treatment of t2d at least in young/middle aged people.

in brief, participants will take part in 2 metabolic studies (a and b) performed in random order and at an interval of 7 to 14 days. each metabolic study will last 8.5 hours with a baseline period of 2.5 hours. participants will ingest either 200 mg of the adrb3 agonist mirabegron (myrbetriq, astellas pharma canada) alone (study a) or in combination with 10 mg of bisoprolol, an adrb1-antagonist (study b), at time 0. the radioactive pet tracers (pet: positron emission tomography) used in this study are the \[11c\]-acetate and \[18f\]-fdg to estimate bat oxidative metabolism and glucose metabolism, respectively. the perfusion of \[6,6 d2\]-glucose, \[1,1,2,3,3-2h\]-glycerol and \[u-13c\]-palmitate stable isotopes will also be performed in this study from time -150 min. to +300 min to examine the systemic appearance rate of glucose, glycerol and fatty acids, respectively. these studies will be almost identical (same perfusion of stable and radioactive tracers, same number of pet acquisitions) except for the drug which will be administered orally at time 0.

Eligibility criteria:
inclusion criteria: * healthy subjects with normal glucose tolerance determined according to an oral glucose tolerance test; * bmi ≤ 30 kg/m2. exclusion criteria: * plasma triglycerides \> 5.0 mmol/l at fasting; * more than 2 alcohol consumption per day; * more than 1 cigarette per day; * history of total cholesterol level \> 7 mmol/l, of cardiovascular disease, hypertensive crisis; * treatment with fibrates, thiazolidinedione, insulin,betablockers or other drugs with effects on insulin resistance or lipid metabolism (exception for antihypertensive drugs, statins or metformin); * presence of a noncontrolled thyroid disease, renal or hepatic disease, history of pancreatitis, bleeding diatheses, cardiovascular disease or any other serious medical conditions; * history of serious gastrointestinal disorders (malabsorption, peptic ulcer, gastroesophageal reflux having required a surgery, etc.); reflux having required a surgery, etc.); * presence of a pacemaker; * have undergone of pet study or ct scan in the past year; * chronic administration of any medication;
belimumab for treatment of cgvhd following allo-hct

Conditions: cGVHD

Summary: given the role of b cells in the pathophysiology of chronic graft versus host disease (gvhd), the association between elevated baff levels post-transplant in abnormal b-cell homeostasis and chronic gvhd, and the efficacy of belimumab in the inhibition of soluble human b lymphocyte stimulator protein (baff) signaling, these proof-of-principle findings support the rational for use of belimumab as treatment of chronic gvhd.the investigators propose a pilot and feasibility study to assess the safety and tolerability, as well as preliminary efficacy, of belimumab a treatment of cgvhd following allogeneic hematopoietic cell transplantation (allohct). the investigators' central hypothesis is that belimumab will be well tolerated and have a favorable effect on chronic gvhd,and we explored therapeutic dosage of belimumab.


Eligibility criteria:
inclusion criteria: 1.18 to 65years old 2.newly diagnosed, moderate or severe chronic gvhd according to the 2014 nih consensus criteria, requiring systemic immunosuppression 3.karnofsky performance status greater than or equal to 60% 4.history of prior allohsct; any donors, conditioning regimens and graft sources are allowed 5.newly diagnosed moderate or severe chronic graft versus host disease (gvhd) (according to the 2014 nih consensus criteria, requiring systemic immunosuppression 6.history of prior allogeneic hematopoietic stem cell transplant (hsct) (any donors, conditioning regimens and graft sources are allowed). 7.stable doses of other immunosuppressive medications (e.g., calcineurin inhibitors, mycophenolate mofetil, rapamune, etc.) with no dose increase in the 2 weeks prior to study treatment initiation. doses may be adjusted for trough levels. 8.patients tested positive for autoantibodies (ana titer ≥1:80) and high baff levels (plasma concentration ≥15ng/ml). 9.laboratory parameters as defined below: serum creatinine less than or equal to 2.0 x uln ast and alt less than or equal to 3 x uln (less than or equal to 5 x uln if unequivocal liver gvhd) total bilirubin less than or equal to 3 x uln 10.ability to understand and willingness to sign a written informed consent fo exclusion criteria: 1. relapsed or progressive malignant disease (other than minimal residual disease) 2. history of other malignant diseases, including post-transplant lymphoproliferative disease 3. rituximab or other anti-b cell-specific antibodies were used in the past 3 months. 4. uncontrolled infections (including prior aspergillosis) not responsive to antibiotics, antiviral medicines, or antifungal medicines 5. donor lymphocyte transfusion for donor chimeric relapse or loss. 6. any other reason at the discretion of the investigators and documented in the medical record that may raise concerns about the subject safety or ability to participate on this study -

Keywords: cgvhd resistance belimumab
transcutaneous electrical muscle stimulation in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: transcutaneous electrical muscle stimulation (tcems) is well established intervention for rehabilitation of clinically stable patients with chronic obstructive pulmonary disease. the investigators have conceived this study to test whether tcems is feasible and tolerated by patients experiencing severe physical and psychical challenge of acutely exacerbated copd.


Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease gold stage iii or iv * acute exacerbation of the disease exclusion criteria: * contraindications for transcutaneous electrical muscle stimulation

Keywords: chronic obstructive pulmonary disease
study to assess the safety and change in disease symptoms of risankizumab (skyrizi) in adult participants with moderate to severe plaque psoriasis and psoriatic arthritis

Conditions: Psoriasis; Psoriatic Arthritis

Summary: plaque psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. psoriatic arthritis (psa) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. it is caused by an overactive immune system where the body attacks healthy tissue by mistake. this study will evaluate how safe risankizumab is for the treatment of plaque psoriasis or psoriatic arthritis and to assess change in disease symptoms. risankizumab is an approved drug for the treatment of psoriasis and psoriatic arthritis. around 3000 adult participants with a moderate to severe plaque psoriasis or psoriatic arthritis who had been prescribed risankizumab by their doctor will be enrolled in this study in multiple sites across korea. the sample size for this study is a requirement by local authorities. participants will receive risankizumab prefilled syringe for injection for 52 weeks as prescribed by their physician. there is expected to be no additional burden for participants in this study. all study visits will occur during routine clinical practice and participants will be followed for 52 weeks.


Eligibility criteria:
inclusion criteria: * suitable for the treatment with risankizumab according to the approved local label. * voluntarily agree to participate in this study and sign informed consent. exclusion criteria: - contraindications to risankizumab as listed on the approved local label.

Keywords: psoriasis plaque psoriasis psoriatic arthritis risankizumab skyrizi prefilled syringe
weight set-point and hdl concentration in runners

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to investigate the differences in diet, fat cell morphology and lipoprotein metabolism in previously- overweight and naturally lean men and women who ran and who lived sedentary lifestyles in order to better understand the relationship between lipoprotein metabolism and weight set-point.

background: the elevated high-density lipoprotein (hdl) cholesterol concentrations of long distance runners has been ascribed almost exclusively to increased muscle lipoprotein lipase. based on data collected in cross-sectional and longitudinal studies, the investigators proposed an alternative theory: long-distance runners had the hdl-cholesterol metabolism of men who were below their sedentary weight rather than the hdl-cholesterol metabolism of lean sedentary men who were at their usual sedentary weight. in other analyses, they found that the most significant determinant of male runners' plasma hdl-cholesterol concentrations was the difference between the runners' greatest weight and their current weight. hdl- cholesterol levels were highest in runners who had lost the most weight, i.e., highest in those who were presumed to be the furthest below their weight set-point the study was a result of a program announcement (pa) released in october, 1994 on physical activity and cardiopulmonary health. the pa was jointly sponsored by the nhlbi, the national institute of diabetes and digestive and kidney diseases, and the national institute of nursing research. design narrative: in this cross-sectional study, runners and sedentary men and women were measured for lipoprotein cholesterol, triglycerides, polyacrylamide gel electrophoresis of hdl and low-density lipoprotein subclasses, apolipoproteins a-i and b, intravenous fat clearance rate, post-heparin lipoprotein lipase and hepatic lipase, adipose tissue lipoprotein lipase, cholesteryl ester transfer activity, diet, percent body fat, and regional adiposity. it was hoped that the survey would confirm or reject the weight set-point hypothesis, provide a possible explanation of the lipoprotein differences between male and female runners, and elucidate the mechanism for the lipoprotein changes that occur during exercise-induced weight loss. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a pk/pd study of cm4620-ie in patients with acute pancreatitis

Conditions: Acute Pancreatitis

Summary: this open-label study will evaluate the pharmacodynamic and pharmacokinetic profile of cm4620-ie in patients with acute pancreatitis. the first five (5) patients will receive ≤ 2.08 mg/kg of cm4620-ie by continuous iv infusion on day 1. if necessary, up to an additional 4 patients may be treated at a different dose of cm4620-ie as determined by the obtained pk and pd data. the infusion of cm4620-ie will start within 12 hours from the time the patient or lar provides informed consent.


Eligibility criteria:
inclusion criteria: 1. diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria: 1. serum lipase and/or serum amylase \> 3 times the upper limit of normal (uln); 2. characteristic findings of acute pancreatitis on abdominal imaging; 2. adults ≥ 18 years of age; 3. a female patient of child-bearing potential who is sexually active with a male partner must be willing to practice acceptable methods of birth control for 365 days after the last dose of cm4620-ie; 4. a male patient who is sexually active with a female partner of childbearing potential must be willing to practice acceptable methods of birth control for 365 days after the last dose of cm4620-ie and must not donate sperm for 365 days; 5. willing and able to, or have a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and cooperate with all aspects of the protocol. exclusion criteria: 1. any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study or may limit expected survival to \< 6 months; 2. suspected presence of cholangitis in the judgment of the treating investigator; 3. any malignancy being treated with chemotherapy or immunotherapy; 4. any autoimmune disease being treated with immunosuppressive medication or immunotherapy (section 5.3 for list of prohibited medications); 5. history of: 1. chronic pancreatitis, pancreatic necrosectomy, or pancreatic enzyme replacement therapy; 2. biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy; 3. known hepatitis b or c, or hiv; 4. history of organ or hematologic transplant; 5. myocardial infarction, revascularization, cardiovascular accident (cva) in the 30 days prior to day 1; 6. current renal replacement therapy; 7. current known abuse of cocaine or methamphetamine; 8. known to be pregnant or are nursing; 9. participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to day 1; 10. history of allergy to eggs or known hypersensitivity to any components of cm4620-ie; 11. prior treatment with cm4620-ie.
risperidone for the treatment of cocaine dependence - 7

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate clinical safety and pharmacological efficacy in the treatment of cocaine dependence, to evaluate impact of treatment on craving, and to correlate evidence of baseline neurotoxic damage of cocaine with treatment outcome and clinical side-effects.


Eligibility criteria:
inclusion criteria: m/f ages 21-50. meet dsm-iv criteria for cocaine dependence. agree to conditions of the study and sign informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nursing women. dependence on etoh or benzodiazepines or other sedative/hypnotics. acute hepatitis. other medical conditions that deem participation to be unsafe.

Keywords: cocaine dependence
virtual reality hypnosis versus inhaled nitrous oxide in anterior shoulder dislocation reduction: an open multicenter randomized controlled trial

Conditions: Shoulder Dislocation

Summary: anterior shoulder dislocation (asd) is a common situation in the emergency department (ed). quick reductions lead to reduced mid and long term complications. no technique is superior to one another. inhaled nitrous oxide can deal with pain reduction and anxiety but its efficacy is not optimal, with safety issues. virtual reality hypnosis (vrh), by distracting patients from their pain, may lead to a better muscular relaxation and an easier asd reduction. our first objective is to evaluate the clinical interest of vhr compared to nitrous oxide, in asd reduction. our second objective is to evaluate the safety of vrh in asd reduction. patients over 18 years presenting an asd \< 24 hours, will be illegible for enrollment in an open multicenter randomized controlled trial, conducted in the great east region in france.


Eligibility criteria:
inclusion criteria: * patients of 18 years and older * consulting the ed for a asd \< 24 hours * with or without history of asd * with social insurance exclusion criteria: * non anterior shoulder dislocation * shoulder or facial fracture or multiple trauma patient * dementia, psychosis * uncontrolled epilepsy * visual or hearing issues * claustrophobia * vascular or nervous lesion of the dislocated arm * contraindication with the use of inhaled nitrous oxide

Keywords: shoulder dislocation virtual reality hypnosis
per oral endoscopic myotomy (poem) and prolonged dilatation (prd) for achalasia

Conditions: Esophageal Achalasia

Summary: achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss. although conventional treatment such as laparoscopic heller myotomy (lhm) and balloon dilatation (bd) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. additionally, treatment after failed lhm or bd can be challenging and in few might even lead to esophagectomy. per oral endoscopic myotomy (poem) and prolonged dilatation (prd) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed lhm. the purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as poem, prd with stent-fixation, pd and conventional lhm for achalasia in an individualized treatment setting.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm exclusion criteria: * contraindication for egd
myhand 2: an active hand orthosis for stroke patients

Conditions: Stroke; Hemiparesis

Summary: this study is designed to further develop and test the hardware and software components of the myhand device based on user feedback and results from our pilot study. the goal is to refine the device so that is more effective and easier for stroke patients to use to increase their hand function.

from previous experimentation with the myhand device, the investigators have determined that the device can improve the grasping ability of stroke patients. the investigators now aim to make the controls more intuitive and accurate for the users, to enable subjects to grasp a wider array of objects, to make the donning and doffing of the device easier, and to continue to assess the myhand as it helps subjects in functional tasks.

Eligibility criteria:
inclusion criteria: * adults over 18 years old * history of stroke(s) with most recent stroke at least six months ago * upper extremity weakness with impaired ability to complete daily activities with affected hand * full passive range of motion in all digits * intact cognition to follow directions * gross control of proximal upper extremity musculature exclusion criteria: * other neurological conditions besides stroke * other orthopedic conditions to affected upper extremity * significant spasticity in affected upper extremity that impairs device fit

Keywords: stroke rehabilitation hemiparesis robotics